MAUDE Adverse Event Report: MEDCARE FULL BODY FLOOR LIFT ; TOTAL LIFT

Model Number 400003

Device Problem Device Slipped (1584)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 06/14/2015

Event Type  malfunction  

Event Description

Two cna's were transferring a pt from bed to wheelchair using the full body floor lift with a care sling when the right leg of sling slipped off the hook on the lift bar causing the resident to slide to the floor onto the legs of the lift.Nursing noted approximately 1cm abrasion to right shoulder.Resident was taken to (b)(6) hospital at 11:50am for further eval, as a precaution.No injuries noted by on call physician, dr (b)(6).

Manufacturer Narrative

The facility indicated, "upon investigation noted the black stopper on the lift was not in the correct placement to hold sling into place.Stopper was repositioned correctly".Also, the facility pointed out, "maintenance does inspect lifts monthly and replaces stoppers.Last inspection was completed 05/15/2015.Nothing unusual noted upon inspection.Maintenance will continue to inspect lifts regularly and cna's educated to monitor stopper positioning closely when using lifts".Medcare representative visited the facility and reported, "nothing wrong with lift".Root cause: improper use of the sling with the lift, by not verifying the strap was correctly positioned post the rubber stop prior to lifting the pt.Medcare representative: (b)(6) , medcare products, mastercare pt equipment, (b)(6).Facility contact person: complaint coordinator phone:(b)(6).

• Brand Name: FULL BODY FLOOR LIFT
• Type of Device: TOTAL LIFT
• Manufacturer (Section D): MEDCARE ; burnsville MN 55337
• Manufacturer Contact: steve kilburn ; 10888 metro ct; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 4929460
• MDR Text Key: 6030912
• Report Number: 3007802293-2015-00023
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 98 YR
• Patient Weight: 69